Biosafety Engineer

Materialise NV; Vlaams-Brabant; On-site; EUR 65,000 - 95,000; Full time

Job summary

Materialise Medical in Belgium seeks a Biocompatibility Engineer to contribute to the biocompatibility evaluation and validation of cleaning, packaging, and sterilization processes for medical devices.

You will work with internal teams and external labs to ensure regulatory compliance and patient safety while developing robust validation protocols and supporting regulatory submissions.

Qualifications

• Master degree in engineering, biochemistry, biology, or medical field.
• Knowledge of regulatory requirements in biocompatibility, cleaning validation, packaging development, or sterilization validation of medical devices.
• Ability to manage multiple projects and establish short- and long-term planning horizons.
• Effective in a team and able to work independently to achieve goals.
• Clear and effective verbal communication and technical writing skills in English.
• Strong analytical skills and meticulous attention to detail.
• Passion for patient safety and customer satisfaction.

Responsibilities

• You ensure the biocompatibility of medical devices and validate cleaning, packaging, and sterilization processes.
• You support biological safety evaluations per ISO 10993-1 and validate cleaning and sterilization; you develop packaging for sterile and non-sterile devices and test performance.
• You plan and finalize validation protocols and reports, ensuring they are clear, concise, and compliant with instructions and standards.
• You coordinate tests with manufacturing teams and external labs to fulfill requirements.
• You act as an ambassador for biological safety within Materialise Medical and collaborate with internal and external partners.

Skills

Biocompatibility evaluation

Regulatory knowledge

Project management

Team collaboration

English communication

Education

Master's degree

Job description

At Materialise Medical, we believe that better healthcare starts with solutions designed around the individual patient. If you’re passionate about bringing personalized care to every patient, you’ll love being a part of this team. Through the technology we develop, researchers, engineers, and clinicians are revolutionizing personalized treatment — helping improve and save lives daily.

Responsibilities

• Within the Medical Business Unit, you are part of the team of specialists that ensure the biocompatibility of our medical devices and that develop and validate their cleaning, packaging, and sterilization processes.
• You participate in medical device development by supporting biological safety evaluations in accordance with ISO 10993-1 and by executing cleaning and sterilization process validations. In addition, you develop new or optimized packaging for sterile and non-sterile medical devices and test their performance. You set up and take part in monitoring programs to ensure continued fulfillment of requirements. You contribute to regulatory submissions of new devices.
• You build a thorough understanding of the manufacturing process, especially the steps related to cleaning, packaging, and sterilization, to effectively plan new development and validation activities. You create and finalize validation protocols and reports, ensuring they are clear, concise, and compliant with work instructions and standards. You assess the impact of the process or product changes and propose adequate actions. You plan and follow up on test sample production with the manufacturing team and with suppliers. You coordinate the tests that are being performed at external test labs.
• You interact closely with internal stakeholders (including the Quality, Regulatory, Development, Process Engineering, and Manufacturing teams) and external partners (including test labs and suppliers) to ensure good communication and swift collaboration.
• You act as an ambassador and safeguard of biological safety within Materialise Medical.

Requirements

• Master degree (engineering, biochemistry, biology, or medical)
• Knowledge and understanding of regulatory requirements, standards, and guidance documents in the field of biocompatibility evaluation, cleaning validation, packaging development, or sterilization validation of medical devices.
• Able to work on multiple projects simultaneously, set priorities, and establish short- and long-term planning horizons.
• Effective as a team member to accomplish project deadlines and objectives, yet able to work and make decisions independently to reach goals.
• Clear and effective verbal communication and technical writing skills in English.
• Good analytical skills, meticulous approach with a high level of attention to detail.
• Passionate about patient safety and customer satisfaction

What’s waiting for you

Work that matters

The technology we build at Materialise pushes the boundaries. You’ll find pride in building something that matters, whether you designed it, printed it, or shipped it. No matter your role, we unlock new possibilities to build a better and healthier world every day.

At Materialise, we expect you to think about the customer, not just the task. You push for better solutions and care about the difference your work makes.

A people-centered space

When you join Materialise, you join a group of colleagues invested in you, not just your work. From your own team to a department across the world, you’ll find a sense of belonging with people who help without being asked, challenge you, and have your back.

At the same time, we expect you to invest in the people around you — not just your own work — to make the group stronger than the sum of its parts.

An environment of trust

As a company of innovators, we know how crucial autonomy is in your work. When we hire you, we trust in your expertise, giving you space to organize your tasks, work flexibly, and make your own calls.

At Materialise, we expect you to deliver on that trust and keep your commitments.

A career ready to build

When you see opportunities for your career to grow at Materialise, we encourage you to go for them. People shape a fulfilling career at their own pace here.

At Materialise, we expect you to take initiative in your own development. Don’t wait for someone else to plan your career. Step into the space and make it count.

Make a difference together with the Medical team.